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RegisterExtent of Protocol deviation accepted by the Agency [Regulatives / Guidelines]
Dear All,
I am performing fasting and fed Bioequivalence studies for an X product. Design of the study is parallel as recommended by the Agency.
Fasting and Fed studies are divided each into 2 groups.
Fed study was completed with 2 groups (Each group with 40 subjects, 20 each of test and reference.
Analysis was done and proved to be bioequivalent.
In fasting study, only group 1 is completed and there's no time for the group 2 to be completed. So can I analyze and if it is bioequivalent, will Agency accepts by proposal (deviation from the protocol that group 2 was not performed?)
Please can you clarify the same
Regards,
Bharathi
I am performing fasting and fed Bioequivalence studies for an X product. Design of the study is parallel as recommended by the Agency.
Fasting and Fed studies are divided each into 2 groups.
Fed study was completed with 2 groups (Each group with 40 subjects, 20 each of test and reference.
Analysis was done and proved to be bioequivalent.
In fasting study, only group 1 is completed and there's no time for the group 2 to be completed. So can I analyze and if it is bioequivalent, will Agency accepts by proposal (deviation from the protocol that group 2 was not performed?)
Please can you clarify the same
Regards,
Bharathi
Complete thread:
- Extent of Protocol deviation accepted by the Agencybharathi 2014-09-16 12:19 [Regulatives / Guidelines]
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Ing. Helmut Schütz